The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Y Clave Connector With Integrated Check Valve, Model Xi-3432.
| Device ID | K042182 |
| 510k Number | K042182 |
| Device Name: | Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 |
| Classification | Set, Administration, Intravascular |
| Applicant | ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Dale Fairchild |
| Correspondent | Dale Fairchild ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2004-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709087153 | K042182 | 000 |